Ignite Creation Date:
2024-07-17 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06467708
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-05-29
Brief Title:
Transcutaneous Auricular Neurostimulation for ICU Patients With Traumatic Brain Injury
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
Delivering Transcutaneous Auricular Neurostimulation tAN to ICU Patients With Traumatic Brain Injury tAN-TBI
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
tAN-TBI
Brief Summary:
The overarching goal of this pilot study is to assess the feasibility and safety of transcutaneous auricular neurostimulation tan in ICU patients with TBi and to determine the effect of tan on serum markers of inflammation exploratory analyses will examine effects on such physiological parameters as blood pressure heart rate and intracranial pressure iCP as well as measures of neurological function
Detailed Description:
This is a single-center open-label nonrandomized investigation TBI patients with a post resuscitation Glasgow Coma Scale GCS score of 12 or less commonly described as moderate or severe TBI and acute traumatic intradural blood on head CT scan will be screened upon admission to the ICU at Parkland Memorial Hospital It is expected that all or almost all subjects will be in the Neuroscience or Surgical ICU Consent for participation will be sought from the subjects legally authorized representative Exception from informed consent or waiver of consent will not be part of this study
tAN will begin as soon as feasible after subject enrollment Immediately prior to this intervention vital signs neurologic status and other clinical parameters will be recorded and pre-tAN blood will be collected for measurement of serum inflammatory markers tAN will be administered for 30 minutes under the supervision of a member of the research team After 30 minutes just prior to stopping tAN the same clinical parameters that were recorded at baseline will again be recorded then tAN will be stopped Approximately two hours after tAN has ended a post-tAN blood sample will be collected for measurement of the same inflammatory markers as in the pre-tAN blood sample At each timepoint for blood collection additional blood may be collected for banking and future analyses
Patients will undergo research blood draws and tAN stimulation for a maximum of 10 days Research-related procedures will not exceed this 10-day period
tAN will begin as soon as feasible after subject enrollment Immediately prior to this intervention vital signs neurologic status and other clinical parameters will be recorded and pre-tAN blood will be collected for measurement of serum inflammatory markers tAN will be administered for 30 minutes under the supervision of a member of the research team After 30 minutes just prior to stopping tAN the same clinical parameters that were recorded at baseline will again be recorded then tAN will be stopped Approximately two hours after tAN has ended a post-tAN blood sample will be collected for measurement of the same inflammatory markers as in the pre-tAN blood sample At each timepoint for blood collection additional blood may be collected for banking and future analyses
Patients will undergo research blood draws and tAN stimulation for a maximum of 10 days Research-related procedures will not exceed this 10-day period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None